The U.S. Food and Drug Administration has amended the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose of the vaccine in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 Vaccine.
What Parents and Caregivers Need to Know:
- Children 6 months through 4 years of age who completed their three-dose primary series with the monovalent Pfizer-BioNTech COVID-19 Vaccine more than two months ago are now eligible to receive a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.
- Since December 2022, children 6 months through 4 years of age who receive the first two doses with monovalent Pfizer-BioNTech COVID-19 Vaccine should complete their three-dose primary series with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. These children in this age group are not eligible for a booster dose of a bivalent vaccine at this time and are expected to have protection against the most serious COVID-19 outcomes. Today’s authorization is for those children 6 months through 4 years of age who completed their 3-dose primary vaccination series with the monovalent Pfizer-BioNTech COVID-19 Vaccine, before the Pfizer-BioNTech COVID-19 Vaccine, Bivalent was authorized to provide the third dose in the 3-dose primary series.
- The Pfizer-BioNTech COVID-19 Vaccine, Bivalent includes an mRNA component corresponding to the original virus strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component corresponding to the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant.
“Today’s authorization provides parents and caregivers of children 6 months through 4 years of age who received the three-dose primary series with the monovalent Pfizer-BioNTech COVID-19 Vaccine an opportunity to update their children’s protection by receiving a booster dose with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Currently available data show that vaccination remains the best defense against severe disease, hospitalization and death caused by COVID-19 across all age groups, and we encourage all eligible individuals to make sure that their vaccinations are up to date with a bivalent COVID-19 vaccine.”
